1. Field of the Invention
This invention relates to the field of medical devices, and more specifically, to an endotrachael intubation device.
2. Prior Art
The use of various-shaped tubing in the medical arts is well recognized. Generally, each tube is specifically configured so as to achieve a specific purpose. For example, U.S. Pat. Nos. 3,908,665 and 4,068,658 are directed to pharyngeal airways. These airways are formed by a specifically shaped tube which is inserted into the mouth and pharynx, and are designed for use in the practice of anesthesiology and resuscitation.
U.S. Pat. Nos. 3,948,274 and 4,050,466 are directed to endotracheal tubes of different configurations. These tubes are designed for insertion through an opening cut in the front of the throat or directly through the mouth and beyond.
Reference is also made to U.S. Pat. Nos. 3,982,546; 3,957,055; 3,894,540 and 3,169,528. Each of these references shows yet other tubing devices used in the medical arts.
While the above prior art devices may provide a specific advantage which is associated with the design of such device, it is not believed that any device could be modified for use in other embodiment. The device of the present invention is also specifically designed. In this case, it is designed for use in connection with the removal of meconium and other materials from the oral airways and trachea region of newborn babies.
The need to remove meconium from a newborn infant is well recognized. Reference is made to an article published in (i) Journal of Pediatrics, December, 1974, Vol. 85, No. 6, pages 848-852 entitled "Meconium Aspiration in Infants--A Prospective Study", and (ii) Am. J. Obstet. Gynecol. 126:712, 1976 entitled "Combined Obstetric and Pediatric Approach to Prevent Meconium Aspiration Syndrome". In that latter article, meconium aspiration syndrome (MAS) is indicated to be a variety of aspiration pneumonia which occurs most frequently in term or past-term newborn infants who have passed meconium in utero. The article indicates that such infants often develop progressive respiratory failure with significant hypoxemia during the first two to three days of life. Death rates as high as 28% have been reported for MAS. Indicated in the article is what is believed to be one of the most up-to-date methods for removing meconium from the newborn infant; to wit: tracheal suction under direct laryngoscopic vision as soon as possible after the birth of the at-risk infant. Recently, intrapartum nasopharyngeal suction has been added as an additional technique. Generally, as soon as the baby's head appears on the perineum, and prior to the delivery of the shoulders, the doctor passes a suction catheter through the nares to the level of the nasopharynx and aspirates any mucus or meconium. The doctor then suctions the mouth and hypopharynx in a similar manner. Because the field into which the catheter is being passed (i.e., a baby's mouth and nose) is small, and irregular in shape, a flexible tubing is often used. Following the delivery, the doctor then with the aid of a laryngoscope shines light and visualizes the area directly above and below the vocal cords looking for meconium. If it is present it must be removed by a suction device (usually a standard endotracheal tube with an internal guide wire) as quickly as possible to try to avoid greater or deeper aspirations of this material. The current art is that the same device that suctions the mouth and nose cannot be used for the trachea because its flexibility makes the intubation process too difficult.
Because proper placement of the endotracheal tube to remove the meconium is critical, the infant is held in position and a doctor or other hospital personnel then inserts the tube which has a stiffening wire inserted therein. The stiffening wire enables the otherwise flexible tube to travel into the trachea. Once in proper position, the stiffening wire must be removed in order to allow the doctor to suck out any meconium in the trachea region. The doctor must place his mouth over the proximal end of the endotracheal tube. Then during suction he must remove the endotracheal tube and dispose of any meconium which has been sucked out. If meconium remains, he must then reinsert the tube in the trachea again with the guide wire stylet and repeat the process as often as needed until no further meconium is retrieved.
The problems with such approach are obvious. Insertion is accomplished with the laryngoscope in one hand and the endotracheal tube and stiffening wire in the other hand. After the tube is inserted, prior to mouth suction, the wire must be removed. To do this the laryngoscope must be placed down to free a hand to remove the wire. This is very awkward and has lead to the accidental removal of the endotracheal tube from the proper position in the trachea. In summary, the problems with a guide wire type intubation device are:
1. Such a device occludes the lumen of the endotracheal tube and which therefore must be removed prior to the application of suction; PA0 2. The wire can only be removed after proper placement; PA0 3. Removal of the wire is often clumsy and can inadvertently dislodge the endotracheal tube from the desired position; PA0 4. The guide wire must be reinserted for reintubation which is often times required; and PA0 5. The laryngoscope must be put aside in order to free a hand to remove stylet prior to suction.
An example of an intubation tube used in the prior art is found in U.S. Pat. No. 3,996,939. In such device, the wire or "stylet" is used in intubating the endotracheal tube, catheter or like medico-surgical tube. The stylet comprises a bendable metal rod hermetically sealed in a tubular plastic sheath such that the rod is contained in the sheath. The tube and stylet are inserted into the trachea region at which time the stylet is removed and suction is applied to the catheter.
The problem with such device is that it is structurally complex. Another problem is the time factor. Removal of meconium is considered to be an emergency procedure in which every second counts. If the infant's head turns and proper insertion cannot be made after a number of tries, the probabilities that the infant will more deeply aspirate meconium is increased. Should the stylet be removed and then proper positioning destroyed, reinsertion may be necessary in order to again achieve proper positioning. Finally, the '939 device is awkward to use as it does not permit the user to simultaneously suction the desired area while holding the laryngoscope during insertion.
Given all of these problems which are well recognized by the prior art, there is still no satisfactory answer which has evolved until the advent of the invention set forth hereinbelow.
It is therefore one object of the present invention to provide a device which can be used to clean the oral and nasal airways prior to the first breath being taken by a newborn infant so as to substantially prevent the aspiration of meconium.
It is yet a further object of the present invention to provide a device which can be easily inserted into the trachea region of a newborn infant so as to remove any meconium from that region as well.
It is yet another object of the present invention to minimize the time associated with the proper insertion of the device.
It is yet another object of the present invention to enable removal of meconium in a substantially more sanitary manner than that associated with the prior art devices.
It is yet another object of the present invention to enable the doctor, while guiding the intubation tubing, to simultaneously suck out meconium and to have a free hand to accurately direct the laryngoscope.
By the use of the device of the present invention, it is believed that a more thorough removal of meconium and other dangerous materials from the oral airways and trachea region of a newborn infant can be achieved. Further, problems caused by repeated intubation are eliminated.